SFDA item 22 · II. Quality changes · II.2 Finished product a) Description and composition
Changes in the composition (excipients) of the finished product
Variation category under SFDA, EU and US FDA rules for this change, with the variant wording as published.
SFDA Saudi Food and Drug Authority
Guidelines for Variation Requirements v6.3 (DS-G-006), item 22 — official PDF, p. 30 ↗
| Variant | Change | Type |
|---|---|---|
| a.1 | Changes in components of the flavoring or coloring system — Addition, deletion or replacement | Type IA(IN) |
| a.2 | Changes in components of the flavoring or coloring system — Increase or reduction | Type IA(IN) |
| a.3 | Changes in components of the flavoring or coloring system — Biological veterinary medicinal products for oral use for which the coloring or flavoring agent is important for the uptake by target animal species. | Type II |
| b.1 | Other excipients — The change relates to a biological/immunological product | Type II |
| b.2 | Other excipients — Qualitative or quantitative changes in one or more excipients that may have a significant impact on the safety, quality or efficacy of the medicinal product. | Type II |
| b.3 | Other excipients — Any new excipient that includes the use of materials of human or animal origin for which assessment is required of viral safety data or TSE risk. | Type II |
| b.4 | Other excipients — Change that is supported by a bioequivalence study. | Type II |
| b.5 | Other excipients — Replacement of a single excipient with a comparable excipient with the same functional characteristics and at a similar level | Type IB |
| b.6 | Other excipients — Any minor adjustment of the quantitative composition of the finished product with respect to excipients (Excluding Biological/Immunological Product) | Type IB |
Conditions to be fulfilled and documentation to be supplied: see the official guideline, item 22.
EU European Union
Commission Guidelines C/2025/5045 — EUR-Lex ↗
Q.II.a.3 · Change in the composition (excipients) of the finished product
| Variant | Change | Type |
|---|---|---|
| a.1 | Change in components of the flavouring or colouring system — Addition, deletion or replacement | Type IA(IN) |
| a.2 | Change in components of the flavouring or colouring system — Increase or reduction | Type IA |
| b.1 | Other excipients — Any minor adjustment of the quantitative composition of the finished product with respect to excipients | Type IA |
| b.2 | Other excipients — Qualitative or quantitative changes in one or more excipients that may have a significant impact on the safety, quality or efficacy of the finished product (for example, biological excipients or a new excipient that includes the use of materials of human or animal origin for which assessment is required of viral safety data or TSE risk) | Type II |
| b.3 | Other excipients — Change that is supported by a bioequivalence study | Type II |
| b.4 | Other excipients — Replacement of excipient(s) with comparable excipient(s) with the same functional characteristics | Type IB |
Note: Changes to oral veterinary biologicals have no counterpart in C/2025/5045, which covers medicinal products for human use.
US FDA US Food and Drug Administration
21 CFR 314.70 and FDA guidance — 21 CFR 314.70(b)(2)(i)–(ii), (d)(2)(ii) · 2004 Guidance §V, §XI.A.1 · 2014 AR Guidance App. A 1.2, App. B 1.2, 1.3, 1.5
| Change | Category | Reference |
|---|---|---|
| Complete or partial deletion of an ingredient that only affects colour, flavour or fragrance | Annual report | 2014 App. B 1.2; 21 CFR 314.70(d)(2)(ii) |
| Immediate-release coating-formulation change (e.g., film-coat colourant) using coating material and quantity approved for a similar product, with no change to release, specs or stability | Annual report | 2014 App. A 1.2 |
| SUPAC level-1 quantitative change in non-release-controlling excipients within the App. B % ranges (release-controlling excipients ≤5% for MR) | Annual report | 2014 App. B 1.3, 1.5 |
| Any other qualitative or quantitative change: adding, replacing or increasing a colourant or flavour, replacing an excipient, larger adjustments, or biological/TSE-relevant excipients | Prior approval supplement | 2004 §V; 21 CFR 314.70(b)(2)(i) |
| Change that requires an in vivo bioequivalence study | Prior approval supplement | 2004 §XI.A.1; 21 CFR 314.70(b)(2)(ii) |
| Veterinary oral product where colour or flavour affects uptake by the target species | No US equivalent |
Note: Apart from the immediate-release coating case (2014 App. A 1.2), only deleting or reducing a colour-, flavour- or fragrance-only ingredient is AR (314.70(d)(2)(ii); App. B 1.2); adding or replacing one is PAS (§V). SUPAC level 2–3 changes remain supplements. Veterinary products are not covered by 21 CFR 314.70; they fall under FDA CVM rules (21 CFR 514.8).
Other items in II.2 Finished product a) Description and composition
- 20 · Change or addition of imprints, bossing or other markings including replacement, or addition of inks used for product marking.
- 21 · Change in the shape or dimensions of the pharmaceutical form*
- 23 · Change in coating weight of oral dosage forms or change in weight of capsule shells
- 24 · Change in concentration of a single-dose, total use parenteral product, where the amount of active substance per unit dose (i.e. the strength) remains the same
- 25 · Deletion of the solvent/diluent container from the pack
Not regulatory advice. The binding text is each regulator's current official document; confirm the category with the authority before filing. FDA publishes no classification table: the US category follows FDA guidance or, where the guidance does not name the change, the closest example under 21 CFR 314.70.